Disposable kit for preparation

ABSTRACT

An apparatus for the manufacture of radiopharmaceuticals includes a lead chamber (6) and a loading device (5) on which a chemical system is mounted in the form of a disposable kit (5). The apparatus includes a first suspension device (9) which functions to move the loading device in a radiation-safe manner between a loading position externally of the lead chamber and a working position within the lead chamber. A second suspension device is provided for releasing a consumed disposable kit from the loading device, such as to enable the consumed kit to fall down into a bottom section (8) of the lead chamber, this bottom section serving as a waste chamber.

The present invention relates to apparatus for the manufacture ofradiopharmaceuticals by chemical reactions based on at least oneradiotracer.

More specifically, the apparatus includes a lead chamber which functionsas a reaction chamber and also as a radiation shield, a number ofcontainers for accommodating said at least one radiotracers and processliquids, at least one card for supporting a given container, saidcontainers being interconnected by means of hoses and valves and alsoconnected to reaction vessels disposed on the card, said card beingintended to be placed in the lead chamber.

An apparatus of this kind is described in our European PatentSpecification No. 0 040 186. One drawback with this known apparatus isthat the hoses of respective reaction vessels are connected by means ofconnecting devices to a coupling plate which serves as the lid of thelead chamber. The vessels are mutually connected together by means ofcoupling hoses which connect the coupling devices one to the otherexternally of the lead chamber. The use of coupling devices of this kindcreates serious sterilization problems. Another drawback with this knownapparatus is that it is necessary to leave the cards in their respectivecard holders until the radioactive radiation in the remaining processliquids has decayed to safe levels. This means that the apparatus cannotbe used again until radioactive radiation has ceased, which limits theoutput performance of the apparatus. The card and the reaction vesselsare again brought into use when the radioactive radiation has ceased.

An object of the present invention is to provide an apparatus of theaforedescribed kind which will eliminate the drawbacks of the knownapparatus.

Another object of the invention is to provide a disposal card which isintended for one-time use only and which is discarded after use.

Another object of the invention is to provide an apparatus of theaforedescribed kind in which used cards fall down into a waste sectionlocated within the lead chamber, whereafter new cards are inserted intothe apparatus and a new radiopharmaceutical manufacturing process isinitiated with the old cards remaining in the waste container in thelead chamber until radiation has decayed to a safe level.

A further object of the invention is to provide an apparatus of theaforedescribed kind with which the radiation shielding function of thelead chamber is maintained while inserting cards into the apparatus.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described in more detail with reference to theaccompany drawings, in which

FIG. 1 is a perspective view of the inventive apparatus;

FIG. 2 is a cross-sectional view of the apparatus illustrated in FIG. 1,and shows the loading device extended out from the apparatus;

FIG. 3 is a cross-sectional view similar to the view of FIG. 2 butshowing the loading device inserted in the apparatus;

FIG. 4 is a view from above of the card, its hoses and injection devicesand shows how the card is mounted in relation to axial stepping motorswhich function to manoeuvre, the plungers of said injection devices;

FIG. 5 is a cross-sectional view of the units shown in FIG. 4, andillustrates the two moveable walls of the loading device in a firstposition in which the walls hold the card firmly therebetween; and

FIG. 6 is a cross-sectional view similar to the view of FIG. 5 butshowing the card holders in mutually separated positions in which theyrelease the card and therewith enable the card to fall down into thewaste container in the lead chamber.

FIG. 1 is a perspective view of the inventive apparatus. The apparatusincludes three sections 1, 2, 3 which are mounted one above the otherand of which the lowermost section 1 forms a waste container forconsumed cards, the section 2 functions as a chemical chamber andsection 3 is an electronics module. Each section 1-3 comprises aframework of mutually joined aluminium panels or plates. The chemicalchamber 2 is provided with an opening 4 in one side panel thereof. Aloading device, identified generally at 5, is moveable through theopening 4 between an extended position, in which a card is loaded forinsertion into the loading device, as described in more detailherebelow, and an inserted position in which the card is located withinthe chemical chamber 2. As will be seen from FIGS. 2 and 3, the wastecontainer 1 is provided with radiation shield means in the form of leadplates which surround the side and bottom walls of the waste containeror chamber. The chemical chamber 2 is also provided with a lead liningwhich functions as a radiation shield and surrounds all side walls ofthe chemical chamber and also its top wall. The lead plates arereferenced 6 in the FIGS. 2 and 3 illustrations. Thus, the lead plates 6delimit an upper section 7 which opens into a lower section 8, thesection 7 forming the chemical chamber 2 and the section 8 forming thewaste chamber 1.

As shown in FIG. 2, the loading device 5 has a first suspension device 9in the form of a piston-cylinder device having two ends 10, 11, of whichone end, 10, is attached to one side wall of the lead chamber and theother end, 11, is connected to the loading device 5. The piston-cylinderdevice is preferably a rodless, linear motion device with the pistonthereof connected to the loading device 5.

In order to ensure adequate protection against radiation in both theextended and the inserted positions of the suspension device 9, theloading device 5 is provided with a respective first and second leadplate 12, 13, which for the sake of clarity have not been shown in FIG.1, but which can be seen from FIG. 2. Each lead plate has a contourwhich corresponds to the contour of the opening 4. When the loadingdevice 5 is extended, as illustrated in FIG. 2, the second lead plate 13will fully cover the opening 4, so as to prevent radiation emanatingfrom consumed cards lying in the lower section 8 from escaping to theambient surroundings of the lead chamber. When the loading device 5 ismoved into the apparatus, as shown in FIG. 3, the first lead plate 12prevents radiation that emanates from the radioactive preparationswithin the lead chamber from escaping to the ambient surroundings.

As illustrated in FIG. 1, the loading device 5 includes a firstmoveable, vertically arranged wall-section 14 and a second moveable,vertically arranged wall-section 15 which is positioned opposite thefirst wall-section 14. The first moveable wall-section is provided witha first card holder 16 which is intended to coact with a second cardholder 17 mounted on the second wall-section 15. The card holders of theillustrated embodiment have the form of two horizontal strips or bars.The second wall-section 15 can be moved away from and towards the firstwall-section 14 with the aid of a second suspension device, not shown inFIG. 1 for the sake of clarity. The directions in which the secondwall-section is able to move in relation to the first wall-section areshown by the double-headed arrow 18 in FIG. 1, while the directions inwhich the first and the second wall-sections 14 and 15 move as a unitare shown by the double-headed arrow 19 in said Figure. This secondsuspension device will be described in more detail herebelow withreference to FIG. 5.

The bottom part of FIG. 4 illustrates a card in the form of a disposablekit in accordance with the invention, while the upper part of saidFigure illustrates a number of activating devices which are disposed ina widened upper-part 20 of the first wall-section 14. The inventivedisposable kit includes a card 21 having the form of an elongated, rigidstrip provided with a row of openings as indicated schematically atreference 22. It will also be seen from FIG. 4 that some of the openings22 are surrounded by sleeves or collars 23 which project out from onemain surface of the card and which are formed integrally with said card.These sleeves are intended to support process-liquid injectors 24 on theinner sleeve surfaces. The sleeves are connected to a system of hosesand reaction vessels, as described more clearly herebelow. Morespecifically, there is included a storage chamber 25 for gas whichcontains the radiotracer to be treated by the chemical system carried bythe card. Provided on the top of the storage chamber 25 is a Luerconnection for a gas hose (not shown). A separation column 27 is coupledto the sleeve or collar of the third ejector from the left as seen inthe Figure, and arranged beneath this separation column is a branch pipe28 having connections which lead to the two ejectors located furthest onthe left and to the storage chamber 25. A hydrolysis chamber 29 ismounted in an opening 22 on the card and is connected by means of hosesin the manner shown in FIG. 4. Finally, the loading device also includesa de-ionizing chamber 30 which includes a millipore filter, among otherthings. The radiopharmaceutical produced in the chemical system on thecard is removed through a pipe 31. Pinch valves, not shown in thedrawings, including a piston-cylinder assembly, function to press a hoseagainst a counterpressure device or anvil means and therewith throttlethe flow or process liquid through the hose. Activation of the valves iscontrolled by the electronics module. The valves are used to guide theprocess liquids between various units on the card. As will beunderstood, the components included in the disposable kit will depend onthe type of starting material used and the kind of end product desired.Consequently, the various chemical process steps will not be describedin detail, since these are not essential to the invention. It isessential to the invention, however, that all reaction vessels,process-liquid containers, gas containers, etc., are arranged on onesingle disposable card 21. The system of hoses and reaction vessels maybe fixedly mounted on a carrier plate (not shown) which, in turn, isconnected to the underside of the card 21. This affixation of the saidcarrier plate and said system may be effected, e.g., by covering thecarrier plate and the system of hoses and reaction vessels with a shrinkfilm material. This shrink-film covering will also serve as asterilization guard.

Each injector 24 includes a cylindrical container 32 having two ends, ofwhich one end carries a flange 33 and the other end carries a taperingcone 34. Each injector also includes a stem 35 having two ends, of whichone end is attached to a piston or plunger (not shown) which moves inthe cylindrical container 32. Mounted in the widened part 20 of thefirst moveable wall-section 14 are a number of axial stepping motors 36.The number of stepping motors used will correspond to the number ofinjectors 32. Each stepping motor has a shaft 37 having two ends. Theshaft 37 moves linearly when the stepping motor is activated. A clampingdevice 38 is mounted on one end of each shaft 37. For the sake ofclarity, only one such clamping device 38 is shown in FIG. 4, althoughit will be understood that each shaft 37 is provided with one suchdevice. The clamping device includes a cylindrical block 39 having asubstantially vertical blind-bore 40, the bottom of which presents afunnel-like widening 41 for guiding the other end of a stem 35 into thebore 40. An optical position sensor 42 functions to detect when said endof the stem has reached the bottom of the blind bore 40. When the stembottoms in the bore 40, a compressed-air pistoncylinder device 43 (shownin FIG. 5) operates to clamp the stem 35 firmly in the bore 40, with theaid of a piston rod 44 which extends through the wall of the cylindricalblock and which functions to urge the injector stem against the wall ofthe cylindrical bore upon activation of the piston-cylinder device 43,said wall of the bore functioning as a counter-pressure surface forclamping the injector stem in the block 39. When the stepping motor 36is then activated, the shaft of said motor will move the injector stem35 and therewith also the injector piston (not shown). Thepiston-cylinder device 43 follows the linear movement of the shaft 37.It will be seen that this arrangement enables process liquids to bemetered very accurately and to be transported through the chemicalsystem.

In order to ensure that the injector cone 34 remains firmly seated inthe sleeve 23 as the shaft 37 moves upwards, the injector is heldpressed into the sleeve with the aid of a lever arm 45 (FIG. 5) havingtwo ends, of which one end is pivotally mounted in the widened part 20of the first moveable wall 14. The pivot point of the lever arm isreferenced 46. The other end of the lever arm is intended for abutmentwith the injector flange 33 and functions to press the injectordownwards. To this end, there is provided a tensioning device in theform of a pressure cylinder 47 which acts on the lever arm 45 in aclockwise direction in FIG. 5. The lever arm 45 also functions to holdthe card 21 securely in position, in abutment with the upper side of thestrip-like card holders 16, 17.

Also shown in FIG. 5 are two heating jaws 48 and 49, which can be movedtowards and away from the separation column 27 for the purpose ofheating the process liquid flowing through said column, movement of saidjaws being effected with the aid of means (not shown), for example acompressed-air piston-cylinder device similar to the piston-cylinderdevice 43. Each heating jaw 48, 49 has the form of an aluminium block inwhich a heat-generating device is mounted, for example an electricalresistance wire. Each heating jaw 48, 49 is moveably mounted in arespective cylindrical housing 50 and 51 which are fixedly mounted onthe first moveable wall 14 and the second moveable wall 15 respectively.Each heating jaw has a front surface provided with an elongated groove.The configuration of respective grooves is such that when the jaws arebrought together to the position shown in FIG. 5, the grooves willencircle the outer surface of the separation column 27.

FIG. 5 also illustrates the aforementioned second suspension device forsuspension of the second moveable wall-section 15. This secondsuspension device includes two piston-cylinder devices 52 which functionto support the moveable second wall 15 at two mutually opposingside-parts thereof. In the case of the illustrated embodiment, thepiston-cylinder device 52 is attached to the first wall-section 14whereas the piston rod 53 of said device is attached to the secondmoveable wall 15. This arrangement enables the moveable wall 15 to movein the directions indicated by the arrow 18 in FIG. 1, between theposition shown in FIG. 5, in which the card 21 is supported by the cardholders 16 and 17, to the position shown in FIG. 6, in which themoveable wall 15 has been displaced to a position in which the card 21rests solely along one long side thereof on the card holder 16 and willtherefore fall gravitationally down into the waste chamber 1, betweenthe two piston-cylinder devices 52.

Movement of the walls 14, 15, movement of the stepping motors,monitoring of the positions of the injector stems, depression of theinjectors into the respective sleeves, and activation of the pinchvalves are all controlled with the aid of known control electronicsmounted in the electronics module 3. All of the process stages can beprogram-controlled, thereby enabling the method to be carried out fullyautomatically, from the moment of manually placing a card in the loadingdevice 5.

The aforedescribed preferred and exemplifying embodiment of theinvention can be modified and changed in many ways within the scope ofthe following claims. For example, several cards can be placedsequentially in line between the first and the second card holders.Instead of only one loading device 5, two or more loading devices may beprovided in the chemical chamber 2. Instead of using rodlesspiston-cylinder devices for the first and the second suspension devices9, 52, there can be used a system of rails and rollers, of which latterone or more of the rollers may be driven. The pressure cylinder 47 maybe replaced with a spring, a magnet or the like.

I claim:
 1. A disposable kit for the preparation of radiopharmaceuticals with a radiotracer as a starting substance, comprising a card in a form of an elongated, rigid strip which is provided with a row of openings comprising one or more first openings and one or more second openings, means mounted around each of said one or more first openings and projecting out from one main surface of the rigid strip in a form of a sleeve for supporting a liquid injector on an inner surface of an inlet end of the sleeve and for connecting a hose at an outlet end of the sleeve, said supporting and connecting means being provided at the first openings but not being provided at the second openings, and a hydrolysis vessel, one opening of said one or more second openings adapted to support said hydrolysis vessel.
 2. A disposable kit according to claim 1, further including a storage chamber, another opening of said second openings adapted to support the storage chamber, the storage chamber having a luer connection.
 3. A disposable kit according to claim 1, further including a de-ionizing column, another opening of said second openings adapted to support the de-ionizing column, the de-ionizing column having connected thereto a discharge hose. 